Currently, China’s medical device market is worth approximately $3.5 billion. Moreover, the number of foreign companies registering medical devices in China nearly doubled between 2003 and 2004. The State Food and Drug Administration (SFDA), which regulates medical devices in China, has been... Read More
In Singapore, medical companies that plan to make a change to one of their pharmaceutical products, such as a change in labeling, packaging or manufacturing site, may submit a minor variation (MIV) application to the Center for Drug Administration under the Health... Read More
To expand their sales in the Asian medical markets, medical companies need to stay abreast of the new and changing regulatory environments for drugs, devices and In Vitro Diagnostics (IVDs). New or improved regulations are implemented frequently in Asia, including changes in... Read More
Despite the country's small size, Singapore boasts a highly-developed economy and serves as an Asian hub for numerous medical companies. In total, Singapore's medical device and pharmaceutical markets are estimated at over $800 million. Leading pharmaceutical companies, such as GlaxoSmithKline, Pfizer, Eli... Read More
In 1998, China’s State Food and Drug Administration (SFDA) introduced Good Manufacturing Practice (GMP) certification in order to emphasize quality and safety of pharmaceutical production. However, the certification was optional and occurrences of medical accidents and legal issues continued to arise due... Read More
Taiwan's medical device market is one of the most advanced in Asia and it continues to be increasingly sophisticated. The market is worth nearly $900 million, making it Asia's 4th largest. Taiwan's domestic industry is growing, but it remains largely fragmented and... Read More
Japan’s Ministry of Health, Labor and Welfare (MHLW) recently published in English, a draft regulation on the requirements for marketing authorization approval for in vitro diagnostics (IVD). The MHLW will evaluate the purpose of use, principle, structure, shape, category specifications, usage, etc.... Read More
Many companies look to India for clinical trials, as the country offers a large, diverse population and varied gene pool. Therefore, patient recruitment is often an easier and faster process in India than in the West and companies can save as much... Read More
In June 2004, Singapore amended its Patent Bill in hopes of strengthening the country’s pharmaceutical patent system. The changes should improve the pharmaceutical sector by encouraging greater innovation and research in Singapore pharmaceutical industry. Specifically, the amended Bill focuses on improving three... Read More
Japan ’s Ministry of Health, Labor and Welfare (MHLW) recently issued a regulation to standardize the names of generic drugs. In the past, some generic drugs were given similar names, often causing confusion and even dispensing errors by pharmacists, doctors and hospitals.... Read More